- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03852199
A Validation Study of Force Sense Measurement
A Validation Study of Force Sense Measurement With a New Instrument
The term proprioception was first introduced by Sherrington in 1906, who described it as a type of feedback from the limbs to the central nervous system. Based on the early descriptions by Sherrington and others, the contemporary terms of joint position sense (JPS), kinaesthesia (perception of active and passive motion), and sense of tension or force sense are considered sub modalities of proprioception.
For the extremity joints, goniometers (universal, bubble, digital) can also be used to measure active JPS. Depending on the device used and the extremity joint measured, reliability and measurement error of active movement goniometry can range widely and this should be carefully considered if goniometry is used to measure active JPS of extremity joints. Kinesthesia, can be measured by calculating the passive motion detection threshold of individuals.
The force sense (FS), commonly assessed using force reproduction, has also been used as a measure of proprioception. Assessing force reproduction by limb matching involves the use of a reference force, usually determined as a percentage of a Maximal Voluntary Isometric Contraction (MVIC), and attempting to replicate that force.
Proprioception can be decreased in those who suffer from knee injury. Because patients with severe degenerative joint disease often require total knee arthroplasty to relieve pain, improve stability, and restore function. Due to problems such as oedema, immobilization and subjective pain after surgery, it is difficult to evaluate proprioception with joint repositioning method. In such cases, the assessment of FS could be of particular interest in the knee region. FS can also be measured by the accuracy of reproducing a specific target force. For example, the pressure biofeedback device (PBD) used for assessing the cranio-cervical flexion test could be considered a method of assessing force sense in the cervical spine. The ability to hold steadily or the accuracy in achieving and maintaining a desired pressure can be used. However, for the knee region, there is no method to measure the force sense via a device that can be used in clinical practice.
The aim of this study was to establish a method for measuring FS that could be applied quickly and practically in the clinic, and to correlate the outcomes with surface electromyographic (EMG) muscle activation levels from M. Quadriceps femoris to demonstrate the applicability and objectivity of this method.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Altindag
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Ankara, Altindag, Turkey, 06030
- Ceyhun Türkmen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- without chronic knee problems
- without chronic neurologic problems
- without chronic rheumatological problems
- without cognitive problems
Exclusion Criteria:
- Osteoporosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Case Group
Our study was performed with 30 healthy individuals at Hacettepe University, Faculty of Physical Therapy and Rehabilitation.
The FS of the knee joint was measured with a Pressure Biofeedback Device (Stabilizer ™, Chattanooga Group Inc., Chattanooga, TN), a device similar to a sphygmomanometer.
To correlate the outcomes of biofeedback device, simultaneously, a surface electromyography (EMG) data of M. Quadriceps femoris muscle activation levels from the individuals were recorded.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measurement of force sensations in mmHg with "Pressure Biofeedback Device" Measurement of Force Sense in mmHg with "Pressure Biofeedback Device"
Time Frame: Participants are evaluated only once in 45 minutes.
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First, the participants were positioned on the exercise bed.
Then, the pressure biofeedback device was placed under the knee joint on the dominant lower extremity side and the cuff was inflated to a pressure of 20 mmHg.
Before the measurement, the participants were told to press their knees to the ground and thus to bring the M.Quadriceps femoris into maximum isometric contraction.
50% and 65% of this maximum value obtained for each individual were recorded as reference values for measuring the force sense error of knee region.
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Participants are evaluated only once in 45 minutes.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 18/932
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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